China-based CStone Pharmaceuticals (HKG: 2616) has announced its 2023 interim financial results alongside key business highlights. The company reported total revenues of RMB 261.5 million (USD 40 million) for the six months ended June 30, 2023, with pharmaceutical product sales contributing RMB 246.9 million (USD 34 million), marking a 53% year-on-year (YOY) growth. The commercial gross profit margin improved from 47% to 59%. CStone reported a healthy financial position with cash reserves of RMB 1,005.4 million (USD 138.3 million) at the end of H1’23. The firm’s net losses amounted to RMB 183 million (USD 25.2 million), representing a 29% decrease YOY.
NDA Approvals and Pipeline Updates
During the period, CStone obtained two New Drug Application (NDA) approvals for pralsetinib: as a first-line treatment for rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) in mainland China, broadening its coverage for pralsetinib in both first-line and second-line NSCLC; and for RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC), and RET fusion-positive thyroid cancer (TC) in Taiwan, China. Currently, five NDAs are under review, including PD-1 inhibitor sugemalimab for relapsed or refractory (R/R) extranodal natural killer/T-cell lymphoma (ENKTL) in mainland China, sugemalimab for first-line stage IV NSCLC in the United Kingdom (UK) and the EU, sugemalimab for first-line gastric adenocarcinoma/gastroesophageal junction adenocarcinoma (GC/GEJ) in mainland China, and sugemalimab for first-line esophageal squamous cell carcinoma (ESCC) in mainland China. The company has received the Good Clinical Practice (GCP) inspection notification from the European Medicines Agency (EMA) for first-line stage IV NSCLC, with an approval decision expected late this year or early next year.
Strategic Collaborations and Distribution Expansion
CStone continued its strategic collaboration with Sinopharm Group Co., Ltd and formed a new partnership with Shanghai Pharmaceuticals Holding Co., Ltd to expand hospital and pharmacy distribution coverage for Gavreto (pralsetinib), Ayvakit (avapritinib), and Tibsovo (ivosidenib). These drugs are now listed in approximately 300 hospitals and direct-to-patient pharmacies (DTPs) as of the announcement date, up from approximately 220 in 2022.
Clinical Trials and Pipeline Developments
CS5001, a best-in-class ROR1 antibody drug conjugate (ADC), has entered global multi-center clinical trials covering the US, Australia, and China, with Phase I exploring multiple dosages completed, producing positive early efficacy and safety data. Additionally, CS2009, a tri-specific molecule against PD-1, VEGF, and another I/O target, is under cell line development, with a first Investigational New Drug (IND) application expected to be filed in 2024. Two other I/O multi-specific programs are progressing through IND-enabling and preclinical candidate (PCC) selection phases, respectively.-Fineline Info & Tech
